The drug supply system is a set of complex interdependent processes from manufacturers to patients: production - examination and registration - inclusion and approval of lists - demand planning - procurement and delivery - dispensing.
Responsibility at each stage is divided among the organizations involved in the chain, in accordance with the competencies and assigned responsibilities.
The first stage of the drug supply system process is the production of medicines, after which the medicines go through the stage of approval for use and permission to sell them on the pharmaceutical market. Drugs, depending on patent protection, can be original or reproduced; trade names may differ from the name of the drug (INN), which is protected by copyright.
The effectiveness of treatment depends on the use of high-quality medicines, and this issue is given special attention in the healthcare system. Just because a drug is approved for use in one country does not mean it is available for use in another country. Thus, there are two types of procedures - state registration and assessment of the quality of medicines after registration.
It all starts with state registration - this is admission to the market. Manufacturers submit an application for registration. The registration procedure is preceded by a thorough examination, which consists of several stages.
The National Center for Expertise of Medicines and Medical Devices carries out the examination and issuance of an opinion. At the registration stage, the effectiveness and safety of the drug, the feasibility of its presence on the market, and issues of compliance with production technology are determined. The results of preclinical, clinical and laboratory tests are being studied.
Issues of the quality of medicines circulating on the market of Kazakhstan fall under the competence of the Committee for Medical and Pharmaceutical Control, which carries out the registration procedure for all medicines produced in the country, as well as those imported into its territory.
Monitoring the safety of drugs and medical devices on the market is also carried out within the framework of the pharmacovigilance system. This is necessary to ensure that the drugs used by Kazakhstanis do not cause more harm than good. The task of pharmacovigilance is to identify, analyze, evaluate and prevent undesirable consequences from the use of drugs.
Yellow cards. If patients detect an undesirable reaction or ineffectiveness of medications and medical devices in treating a disease, they can contact their doctor to fill out a yellow message card on the website of the National Center of Expertise - www.ndda.kz.
At the stage of registration of the drug, maximum prices are also registered for both free provision and retail. Limit prices are formed on the basis of statements from manufacturers and analysis of prices registered in reference countries.
The price analysis is carried out by NCME and sent for approval to the Ministry of Health of the Republic of Kazakhstan. The pricing policy for medicines and medical devices is not within the competence of the Unified Distributor.
Thus, during registration, the parameters of quality, safety, effectiveness, as well as prices that a specific pharmaceutical product must meet are approved.
Manufacturers submit an application for the inclusion of medications in clinical protocols. Recommendations for improving clinical protocols and drug provision are developed and included by the Joint Commission on the Quality of Medical Services of the Ministry of Health of the Republic of Kazakhstan - www.nrchd.kz.
Based on clinical protocols, the Formulary Commission of the Ministry of Health considers the inclusion of medications in the Lists. The tasks of the formulary commission are to develop recommendations for the rational use of drugs, review clinical guidelines, diagnostic and treatment protocols, treatment standards developed for use in the Republic of Kazakhstan, as well as prices for them, participate in the development and approval of targeted drug provision programs, and promote the ethical promotion of drugs.
After which, the Ministry of Health of the Republic of Kazakhstan approves clinical protocols, the Kazakhstan National Drug Formulary, Lists of outpatient medical care and the Unified Distributor for purchase within the framework of the Guaranteed Volume of Free Medical Care and in the Compulsory Social Health Insurance system, which contain: characteristics of medicines, international non-proprietary name and their limits prices.
Medical organizations themselves keep records of patients and determine their own needs both by the names of medications and by volumes, dosages, forms and delivery schedule. The budget is also formed independently within the framework of the available financial resources of medical organizations.
Medical organizations submit a completed application with information on the required names, volumes, dosages and delivery schedule of drugs to the Unified Distributor through the Unified Pharmaceutical Information System.
The application goes through the approval stage with the Health Administration, after which it is transferred to the Social Health Insurance Fund for further approval.
The Social Health Insurance Fund, being a source of financing for outpatient drug provision, considers applications from medical organizations submitted to the Unified Distributor.
Then the Fund sends to the Unified Distributor the calculations of the region's need for medicines within the framework of outpatient drug provision, agreed with the Health Departments - a consolidated register.
Only after coordination and approval of applications by the Social Health Insurance Fund, the Unified Distributor begins purchasing. Thus, calculations of needs from the Fund serve as the basis for procurement procedures.
Thus, SK-Pharmaceuticals does not participate in the process of generating the application. A Unified Distributor carries out procurement and delivery in accordance with the requests of medical organizations.
Procurement procedures are regulated by the Rules for the Organization and Conduct of Procurement, approved by Order of the Minister of Health of the Republic of Kazakhstan No. 110.
The purchase of drugs is carried out on the basis of applications submitted to the Unified Distributor by medical organizations within the framework of inpatient care and the Social Health Insurance Fund within the framework of outpatient drug provision.
As a rule, the Unified Distributor carries out purchases in advance. So, drugs for the next year are purchased already in the current year.
Since 2018, purchases have been carried out in electronic format on a specially developed platform of the Center for Electronic Finance of the Ministry of Finance of the Republic of Kazakhstan. All announcements and protocols of procurement results are open information and are freely available on the web portal for the procurement of medicines and medical devices.
As for the supply of medicines, the Unified Distributor carries out shipment in accordance with the schedule specified in the application. Let us remind you that medical organizations themselves indicate the delivery schedule for the necessary medications.
Prescription sales of medicines in the Republic of Kazakhstan are regulated by the Rules for prescribing, recording and storing prescriptions, approved by order of the Ministry of Health of the Republic of Kazakhstan. Prescriptions are written and dispensed by medical workers of healthcare organizations within their competence if there are appropriate medical indications.
Thus, the purpose, dosage and amount of the medicine dispensed is determined by the attending physician. Information about the provision of medicines is transferred to the Social Health Insurance Fund, after which the registers are reconciled and payment for the provision of medicines is made.
Feedback. In order to monitor issues of free drug provision and work directly with patients, the Unified Distributor operates a contact center with the short number 1439. It accumulates all data from the population about supply disruptions, provides information on the timing and dates of delivery of necessary medications, which are dispensed free of charge.
All calls are free and available for landline and mobile phones.
Consultation on issues of compulsory social health insurance can be obtained from the contact center at number 1406. Calls from mobile and landline phones throughout Kazakhstan are free.
The drug provision system is a rather labor-intensive and time-consuming process. Thus, when a particular drug is given to a patient, the drug goes through all stages of implementation. Each step is regulated by clear regulatory and legal requirements.
The main task is to organize work in such a way that the medicine supply system can quickly and clearly respond to changes in demand, be flexible in any emergency situation and focus primarily on the needs of citizens.
Providing citizens with high-quality and effective medications has always been a priority in preserving the health of the nation. Thanks to the established system, it is possible to uninterruptedly provide patients with access to safe and affordable medicines, as well as to balance the interests of all participants in the pharmaceutical market: consumers, the state and entrepreneurs involved in the pharmaceutical business.
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